Events

Alerta De Seguridad para Freedom Driver System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por SynCardia Systems.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2018-02-28
  • Fecha de publicación del evento
    2018-02-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180228a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: syncardia freedom driver system the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning syncardia freedom driver system used with the syncardia temporary total artificial heart (tah-t) [model number: 595000-001], manufactured by syncardia systems. the manufacturer is making changes to the manuals and labeling of the freedom driver system model no. 595000-001 that will strengthen existing warnings for users with regard to freedom driver drops, rough handling and exposure to liquid/debris. according to the manufacturer, the updates to the warnings in the freedom driver system manuals and labeling will enhance the safe use of the freedom driver system. if the freedom driver is dropped, exposed to liquid/debris or subjected to rough handling, it may sustain damage that will not allow it to provide life-sustaining functions as designed. serious injury or death could occur because of the failure of a freedom driver. in the event that a patient’s freedom driver is dropped, subjected to rough handling or exposed to liquid/debris, the patient must switch to the backup freedom driver. the manufacturer is conducting a voluntary field safety corrective action to reinforce these changes by informing freedom driver customers of the changes and ensuring that the clinical staff and patients review the changes and that the patients are trained on the new labeling. for details, please refer to the following mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-19-to-23-february-2018 according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 february 2018.

Device

Freedom Driver System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SynCardia Freedom Driver System
  • Manufacturer
    SynCardia Systems

Manufacturer

SynCardia Systems